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The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL (KLL2)

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ClinicalTrials.gov Identifier: NCT00919321
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : February 19, 2014
Sponsor:
Collaborators:
Turku University Hospital
Finnish Institute for Health and Welfare
Information provided by (Responsible Party):
MSinisalo, Tampere University Hospital

Study Description
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Brief Summary:

Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our previous studies.

The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and the function of memory cells by giving a one dose of PPV-vaccine after several years of PCV-vaccination.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia (CLL) Biological: Pneumococcal polysaccharide vaccine (PPV) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
PPV Biological: Pneumococcal polysaccharide vaccine (PPV)
One intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. Antibody response [ Time Frame: 1-3 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • CLL patients and controls who have been vaccinated with PCV in our previous study

Exclusion Criteria:

  • Vaccinated with PPV-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919321


Locations
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Finland
Tampere University Hospital
Tampere, Finland, FIN 33521
Sponsors and Collaborators
Tampere University Hospital
Turku University Hospital
Finnish Institute for Health and Welfare
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MSinisalo, Dr, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT00919321    
Other Study ID Numbers: R09082M
2009-012099-29 ( EudraCT Number )
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: March 2012
Keywords provided by MSinisalo, Tampere University Hospital:
CLL
PPV
PCV
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs